Requests for authorised prescriber endorsement

Requests for authorised prescriber endorsement

To apply to the St Vincent’s Hospital (Sydney) HREC for endorsement to apply to the TGA as an Authorised Prescriber, clinicians are required to submit the following:

• Completed Application for HREC endorsement for the purpose of becoming an Authorised Prescriber (required for both new and renewal applications)
• Consumer medical information if the product is approved in another country
• Relevant literature regarding product use
• For devices, a copy of the manufacturer instructions for use
• A copy of the completed TGA form; ‘Agreement to treatment directions authorisation of prescribers under section 19(5), 32CM or section 41HC of the Therapeutic Goods Act 1989’
• For renewal applications, 6 monthly reports which have been submitted to the TGA
• Any other documents relevant to submission